CompletedNCT04108416Updated Oct 1, 2019

Unilateral Cleft Repair in One Surgery With Pure Primary Healing

An observational study in Cleft Lip and Palate, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type: Observational
Model: Case-only
Time perspective: Retrospective
Enrollment: 11
Ages: Up to 2 Years
Sex: All

Study summary

Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Conditions studied

Cleft Lip and Palate

Browse trials for

Cleft Lip 162

Keywords

cleft lip
cleft palate
cleft lip and palate
orofacial cleft

In context

Cleft Lip

162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's enrollment of 11 is below the median of 100 across 45 observational studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 2 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland

Inclusion criteria

newborn patients with complete unilateral cleft lip and palate

Exclusion criteria

Exclusion Criteria:

with associated syndrome
previous lip/ palate repair
previous presurgical orthopaedics other than passive palatal plate

Study design

Observational model: Case-only
Time perspective: Retrospective
Enrollment: 11 participants (actual)
Patient registry: No

Interventions

ProcedureCleft lip and palate repair
The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel

What researchers measure

Primary outcomes

Cleft size measurement
Cleft size is measured before and after passive palatal plate therapy
Time frame: Measured on a model after birth and at surgery with 8 month of age

Secondary outcomes

Wound healing
Full primary healing of the former cleft, no fistula formation, no oronasal leaking
Time frame: 1, 3 and 6 month after surgery
Adverse events
Surgical and anaesthesia-relate adverse events
Time frame: 6 month

Study locations

1 site

Universitätsspital Basel
Basel, 4310, Switzerland

References and documents

Publications

Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available. PubMed 4873510 ↗
Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23. Erratum In: Plast Reconstr Surg. 2005 Jul;116(1):361. PubMed 15861051 ↗
Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1. PubMed 22551772 ↗
Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1. PubMed 16526922 ↗
Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3. PubMed 34896005 ↗

Individual participant data

Plan to share: No — without further approval by our ethical commission individual participant data is not available to other researchers

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04108416
Lead sponsor: University Hospital, Basel, Switzerland
Responsible party: Benito Benitez (Principal Investigator, University Hospital, Basel, Switzerland) — Principal investigator
First posted: Sep 30, 2019
Start date: Jan 1, 2014
Primary completion: Dec 31, 2018
Completion: Jun 30, 2019
Last update: Oct 1, 2019

Study contacts

Benitez Benito, MD DMD

principal investigator · University of Basel and University Hospital Basel

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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